BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPO2 CABLE

    MDR report key: 22884941 · Received August 25, 2025

    Report

    Report Number
    22884941
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    May 24, 2025
    Report Date
    August 18, 2025
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
    Product Code
    DQA
    UDI-DI
    00884838011946
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SPO2 [PERIPHERAL OXYGEN SATURATION] ADAPTER CABLE FAILED TO TRANSMIT DATA FROM PULSE OXIMETER FINGER PROBE TO MONITOR. THIS CAUSED A DELAY IN PATIENT CARE BECAUSE THE ADAPTER CABLE HAD TO BE REPLACED IN ORDER TO OBTAIN A READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616761 SPO2 CABLE OXIMETER DQA PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH SP02 8-PIN D-SUB ADAPTER CABLE 3M (8PIN) 325 00884838011946

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown